Britain’s medicines regulator has approved a new treatment for cancer patients suffering from fluid build-up in the abdomen when their disease can no longer be treated with standard therapies, according to the Medicines and Healthcare products Regulatory Agency.
The MHRA granted approval on 2 October for catumaxomab, marketed as Korjuny, to treat malignant ascites in adults. The condition involves accumulation of fluid containing cancer cells in the abdominal cavity, forcing patients to undergo repeated drainage procedures.
Catumaxomab works as a monoclonal antibody – a type of protein engineered to target specific cells. It binds to epithelial cell adhesion molecule (EpCAM), a protein found on the surface of certain cancer cells present in ascitic fluid, and activates the immune system to destroy those cells.
Clinical trial results
A key clinical study involving 258 patients with malignant ascites and EpCAM-positive cancer demonstrated significant benefits. Participants had either exhausted chemotherapy options or were unsuitable candidates for further chemotherapy.
Results showed that patients who received catumaxomab following paracentesis – the standard drainage procedure – went approximately 46 days before requiring another drainage, according to the government statement. By comparison, those treated with paracentesis alone needed repeat drainage after just 11 days.
Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said the condition “can place a considerable burden on people living with cancer, particularly when further treatment options are limited.”
“This approval provides an additional treatment option that can help extend the time patients live without needing another procedure to drain fluid from their abdomen,” he added.
How the treatment is given
The drug must be administered under supervision of a doctor experienced in treating cancer. It is delivered through a catheter inserted directly into the abdominal cavity as four separate infusions, with the dose gradually increased at each session.
Common side effects include nausea, vomiting, diarrhoea, abdominal pain, fever, chills, fatigue and cytokine release syndrome – an inflammatory reaction triggered when the immune system is activated. The MHRA stated it will continue monitoring the drug’s safety closely, as it does with all licensed medicines.
Healthcare professionals and patients are encouraged to report any suspected adverse reactions through the MHRA’s Yellow Card scheme. The marketing authorisation was granted to Atnahs Pharma UK Limited under the International Recognition Procedure.
What this means for Poles in the UK
Polish residents living in Britain who are dealing with advanced cancer will have access to this new treatment option through the NHS, provided they meet the clinical criteria. Malignant ascites typically occurs in late-stage cancers of the ovary, breast, colon, stomach and pancreas when standard treatments are no longer working.
If you or a family member are affected by this condition, speak to your oncologist or cancer specialist to determine whether catumaxomab might be appropriate. The treatment is only suitable for patients with EpCAM-positive cancer cells and must be given in a hospital setting by experienced cancer doctors.
The drug’s approval means it can be prescribed on the NHS, though individual treatment decisions depend on clinical assessment. Detailed information about the medication, including a Patient Information Leaflet in English, will be published on the MHRA Products website within seven days of the approval date. Anyone experiencing side effects should report them via the Yellow Card scheme at yellowcard.mhra.gov.uk or by searching for “MHRA Yellow Card” online.
